MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 09/15/2010

Event Type  Injury  

Event Description

It was reported that the patient presented to surgery with lumbar fusion l1-s1, compression fracture l1, spinal instability, increase of left lumbar lordosis, and kyphosis.Patient underwent a procedure for redo l2-s1 fusion plus t9-s1 fusion instrumentation with placement of transpedicular screws at t9, t10, t11, and t12; removal of l1 pedicle screws; revision of interbody fusion l1-l2 with revision of the l1-l2 cage; l1 kyphoplasty.At 3 weeks post-op, the patient presented to surgery with a wound infection and underwent a procedure for exploration of lumbar fusion with a wound revision, debridement of the skin and muscle tissue.

Manufacturer Narrative

(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4241703
• MDR Text Key: 17259485
• Report Number: 1030489-2014-04321
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2012
• Device Catalogue Number: 7510800
• Device Lot Number: M110812AAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2014
• Initial Date FDA Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PEDICLE SCREW, ROD, CAGE, DBM, AUTOGRAFT
• Patient Outcome(s): Required Intervention
• Patient Age: 00048 YR